Five minutes at DCAT with …
Michael Lehmann, EVP of Global Sales & Marketing at Patheon
Patheon is a contract development and manufacturing organisation (CDMO) active in the pharmaceutical industry, which describes itself as the “only end-to-end provider of pharma development and manufacturing services”.
Lehmann: We have just acquired a cGMP API facility from Roche in Florence, South Carolina, which significantly changes the manufacturing landscape for us. The site covers 1,100 acres (445 hectares), with 300,000 ft2 (27,900 m2) of manufacturing footprint, with reactors ranging from 50 to 11,000 litres and about 200 employees. As well as greatly expanding our drug substance capacity in general, this adds to our capabilities in the manufacturing of highly potent compounds and gives further support for solid-state chemistry, micronisation and eventually, commercial spray drying. This increased North American presence has great importance for us in API development and commercial manufacturing, supporting products from clinical-scale to commercial manufacturing Spray drying is also coming down the line for us.
PH: A lot of companies call themselves CDMOs these days. What is different or unique about Patheon?
Lehmann: One of the things that is unique about Patheon is the breadth of our coverage. We have competitors in every segment, but when you look at drug substance development, drug substance API and biologics development and manufacturing and drug product development and manufacturing, there is no-one quite like us who has got that spectrum. What I hear generally is that some CMOs, typically those known for commercial manufacturing, are trying to make their way more and more into development and it wouldn’t surprise me if that is a real trend. It’s different but for us, ‘start here, stay here’, doing the product development or the API development, then for the products that survive, to be able to take it commercial, that’s a big feeder into our commercial manufacturing business. According to the annual PharmSource CMO Scorecard, Patheon supported about 30% of all New Drug Application (NDA) approvals on behalf of clients in 2016 – 17 out of 55, which was over four times more than our closest competitor. We also won about 25% percent of all outsourced new molecular entity (NME) and non-NME NDA approvals over the decade from 2007 to 2016, with a total of 112, as many as the next six CMOs combined. Furthermore, Patheon was the only CMO to be recognised for having multiple approvals for both drug substance and drug product.
PH: Are you mostly in small or large molecules as an API manufacturer?
Lehmann: We are very proud that Patheon has both small and large molecule API manufacturing capabilities. The breakdown by large and small molecule API is driven by the needs of the market. We have a broad range of clients – from big pharma to small start – ups, so we focus on meeting the needs of the breadth of clients. A key driver is the fact that 80 percent of new molecules are held by small and emerging companies. Our strategy is getting started in the development phase and keeping that client through development scale to commercial – whether it is a small or large molecule.